Audit-Ready at All Times: Streamlining GxP Computerized Systems Compliance and Inspection Preparedness
Friday, May 9
11:00AM – 12:15 PM EST
Presented by: Era Sciences
As regulatory scrutiny around computerized systems continues to grow, staying inspection-ready is no longer optional. In this webinar, we’ll explore how life sciences teams are enhancing oversight, validation, and audit preparedness across both GxP and GCP environments. You’ll learn why maintaining a reliable, compliant, and up-to-date asset list of computerized systems is essential during inspections—and why tracking them in Excel is one of the most common (and avoidable) compliance pitfalls. Whether you’re scaling into manufacturing or strengthening existing processes, this session will give you practical strategies to stay ahead of regulatory expectations.
What attendees will learn
- Why regulatory agencies are increasingly focusing on computerized systems across both GxP and GCP environments—and what that means for your compliance strategy.
- How to build and maintain a compliant, inspection-ready system portfolio that meets evolving expectations for traceability, validation, and oversight.
- The risks of using Excel or other manual tools for tracking computerized systems—and how this common practice can lead to audit findings.
- Practical strategies to streamline system validation and audit preparation, reducing time, effort, and the risk of noncompliance.
- What high-performing life sciences teams are doing differently to stay ahead during their clinical-to-commercial transition or in optimizing existing operations.
Takeaway tools
- Sample SOP Template: “Generation, Use and Management of Electronic Logs”
- Insights Report on the current state of GxP Systems Management, “The 2025 State of GxP Computerized Systems Validation in Life Sciences”
